UMIN-CTR Clinical Trial

Basic information
Public title	predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Acronym	predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Scientific Title	predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Scientific Title:Acronym	predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Region	Japan

Condition
Condition	pulmonary hyper tension
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine an index to predict rising pulmonary artery pressure during exercise in patients with pulmonary hypertension from the time of rest
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mPAP-co slope during exercise
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Case in which right heart catheter examination with exercise load was performed and consent regarding use of the examination result was obtained
Key exclusion criteria	Case in which agreement on use of examination result was not obtained
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuki Middle name Last name Tobita
Organization	kyorin university hospital
Division name	Department of Rehabilitation
Zip code	1818611
Address	6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan
TEL	0422-47-5511
Email	skazuki1107@gmail.com

Public contact
Name of contact person	1st name Kazuki Middle name Last name Tobita
Organization	kyorin university hospital
Division name	Department of Rehabilitation
Zip code	1818611
Address	6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan
TEL	0422-47-5511
Homepage URL
Email	skazuki1107@gmail.com

Sponsor
Institute	kyorin university hospital department of rehabilitation
Institute
Department

Funding Source
Organization	Japanese association of cardiac rihabilitation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	no
Name of secondary funder(s)	no

IRB Contact (For public release)
Organization	kyorin university
Address	6-20-2, shinkawa, mitaka, tokyo, japan
Tel	0422-47-5514
Email	rec@ks.kyorin-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	杏林大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 19 Day

Related information
URL releasing protocol	https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf
Publication of results	Unpublished

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf
Number of participants that the trial has enrolled	30
Results	Increased pulmonary artery pressure during exercise was associated with increased ventilation at rest.
Results date posted	2022 Year 09 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients in the exercise PH group (71 years:range 61-76) were significantly older than those in the non-exercise PH (46 years: range 37-55). We found no significant differences in each group for height, weight, PH background factors, and several cases receiving continuous intravenous injections of medical agents or type of oral medication. The mPAP-CO slope was 4.9 (range, 4.0-6.4) and 2.0 (range, 1.8-2.5) for the exercise PH and non-exercise PH groups, respectively.
Participant flow	Various evaluations during hospitalization for follow-up right heart catheterization purposes
Adverse events	none
Outcome measures	association between exercise-induced ph and resting parameters.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 03 Month 16 Day
Date of IRB	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cross-sectional study

Management information
Registered date	2018 Year 03 Month 17 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036272